BRIDGE Device for Post-operative Pain Control (BRIDGE)

Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation

Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigator propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

Study Overview

• Status: Terminated
• Conditions: Liver Diseases; Liver Failure; Pain, Postoperative; Liver Diseases, Alcoholic; Liver Cirrhosis, Biliary; Transplant; Failure, Liver
• Intervention / Treatment: Device: BRIDGE device

Detailed Description

This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:

Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia

Group 2: Subjects will receive the standard of care pain control analgesia

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria:

  • ≥18 years of age but <70 years of age
  • Actively listed for isolated liver transplantation
  • Subject or legally authorized representative able to sign informed consent
  • Not currently treated with opioids or any medications that may interact with opioids
  • English speaking
  • Willing and able to participate and consent to this study

Exclusion Criteria:

• Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)
• Anticipated that the subject will require a new roux-en-y hepaticojejunostomy
• Current use of opioid use or other substance abuse.
• Chronic pain disorders
• Need for regional anesthesia (regional nerve blocks or epidurals)
• Adhesive allergy/sensitivity
• Subject admitted to the ICU at the time of transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia	Device: BRIDGE device; an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect
No Intervention: Group 2; Subjects will receive the standard of care pain control analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid usage after surgery as measured by based on daily number of doses and total morphine equivalents used at different time points during the post-operative course.	Determination of the usage of opioid usage after surgery in the two groups being SOC and with device.	up to day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery	up to day 30
reduction in nausea scores as measured by a 4-item questionnaire response	Determination of the intensity of nausea in the two groups (SOC and with device)	up to day 30
reduction in vomiting scores as measured by a 4-item questionnaire response	Determination of the intensity of vomiting in the two groups (SOC and with device)	up to day 30
Reduction in time for return of bowel function as measured by length to time of bowel functioning return.	Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.	up to day 30
Incidence of post-operative ileus will be measured by need for nasogastric decompression for >48 hours	Determination of the presence of an ileus in the two groups (SOC and with device)	up to 30 days
Improved post-operative mobility as measured by the patient symptom surveys	Determination of mobility with in the two groups (SOC and with device)	up to 30 days
Reduction in length of hospital stay as measured by days in hospital	Determination of length of hospital stay with in the two groups (SOC and with device)	up to 30 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Alicia Mavis, MD, Duke Universtity

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): April 3, 2020

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Alcohol-Induced Disorders; Cholestasis, Intrahepatic; Cholestasis; Liver Diseases; Pain, Postoperative; Liver Failure; Liver Cirrhosis; Liver Cirrhosis, Biliary; Liver Diseases, Alcoholic
• Other Study ID Numbers: Pro00084620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No